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  • May 31, 2016
  • General

ACADIA Pharmaceuticals Announces NUPLAZID™ (pimavanserin) Is Now Available for the Treatment of Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis

NUPLAZID is the First and Only FDA-Approved Drug for thisIndication

An Estimated 40 Percent of Parkinson’s Disease Patients HavePsychosis

SAN DIEGO—(BUSINESS WIRE)—May 31, 2016—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesto address unmet medical needs in central nervous system (CNS)disorders, today announced that NUPLAZID™ (pimavanserin) is nowavailable for prescription in the United States. NUPLAZID was approvedby the U.S. Food and Drug Administration (FDA) on April 29, 2016 for thetreatment of hallucinations and delusions associated with Parkinson’sdisease psychosis.

NUPLAZID is the first and only drug approved by the FDA for thisindication. NUPLAZID is also the only drug approved by the FDA thatpreferentially targets 5-HT2A receptors. These receptors arethought to play an important role in Parkinson’s disease psychosis. Theunique pharmacology of NUPLAZID establishes a new class of drug -selective serotonin inverse agonists (SSIA) - by not only preferentiallytargeting 5-HT2A receptors but also avoiding activity atdopamine and other receptors commonly targeted by antipsychotics.Typical Parkinson’s disease therapy consists of drugs that stimulatedopamine to treat patients’ motor symptoms such as tremor, musclerigidity and difficulty with walking. NUPLAZID does not interfere withpatients’ dopaminergic therapy and therefore does not impair their motorfunction.

“I am delighted that we now have an effective and FDA-approved therapyfor patients with hallucinations and delusions associated withParkinson’s disease psychosis,” said Neal Hermanowicz, M.D., HealthSciences Clinical Professor, Neurology, UC Irvine School of Medicine andDirector, UC Irvine Movement Disorders Program. “In the pivotal PhaseIII study of NUPLAZID, we observed significant reductions in theseverity and frequency of hallucinations and delusions in patients withParkinson’s disease psychosis. Importantly, these benefits were achievedwithout impairing motor function.”

According to the National Parkinson Foundation, about one million peoplein the United States and from four to six million people worldwidesuffer from Parkinson’s disease. An estimated 40 percent of thesepatients have Parkinson’s disease psychosis, which is characterized byhallucinations and delusions, is associated with significant caregiverburden, and is a major reason for nursing home placement amongParkinson’s patients.

“We believe NUPLAZID fills an important therapeutic gap as the firstFDA-approved treatment for patients afflicted with hallucinations anddelusions associated with Parkinson’s disease psychosis,” said SteveDavis, ACADIA’s President and Chief Executive Officer. “We are excitedto bring this new treatment option to patients living with thechallenges of this debilitating condition.”

NUPLAZIDconnect™ Patient Access and Support Services

ACADIA is committed to ensuring that patients in the United States whoare prescribed NUPLAZID are able to access the medicine and receive theongoing support they may need. ACADIA has established NUPLAZIDconnect™,a comprehensive program that provides access assistance to patients,their caregivers, and physicians, as well as financial assistance tothose patients who qualify. NUPLAZID is available through a specialtypharmacy network. Patients and physicians can access information aboutNUPLAZID and NUPLAZIDconnect by visiting www.nuplazid.comor calling 844-737-2223.

About NUPLAZID (pimavanserin)

NUPLAZID is the first FDA-approved treatment for hallucinations anddelusions associated with Parkinson’s disease psychosis. NUPLAZID is anon-dopaminergic, selective serotonin inverse agonist preferentiallytargeting 5-HT2A receptors that are thought to play animportant role in Parkinson’s disease psychosis. NUPLAZID is an oralmedicine taken once a day with a recommended dose of 34 mg (two 17 mgtablets). ACADIA discovered this new chemical entity and holds worldwiderights to develop and commercialize NUPLAZID. Please see fullprescribing information at www.nuplazid.com.For additional information and multimedia assets on NUPLAZID, click here http://www.businesswire.com/news/home/20160429006144/en/

Important Safety Information and Indication for NUPLAZID(pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITHDEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated withantipsychotic drugs are at an increased risk of death. NUPLAZID isnot approved for the treatment of patients with dementia-relatedpsychosis unrelated to the hallucinations and delusions associatedwith Parkinson’s disease psychosis.

NUPLAZID is an atypical antipsychotic indicated for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis.

QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use ofNUPLAZID should be avoided in patients with known QT prolongation or incombination with other drugs known to prolong QT interval includingClass 1A antiarrhythmics or Class 3 antiarrhythmics, certainantipsychotic medications, and certain antibiotics. NUPLAZID should alsobe avoided in patients with a history of cardiac arrhythmias, as well asother circumstances that may increase the risk of the occurrence oftorsade de pointes and/or sudden death, including symptomaticbradycardia, hypokalemia or hypomagnesemia, and presence of congenitalprolongation of the QT interval.

Adverse Reactions: The most common adverse reactions (≥2%for NUPLAZID and greater than placebo) were peripheral edema (7%vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination(5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).

Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole)increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half.

Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reducedefficacy. Increase in NUPLAZID dosage may be needed.

Renal Impairment: No dosage adjustment for NUPLAZID is needed inpatients with mild to moderate renal impairment. Use of NUPLAZID is notrecommended in patients with severe renal impairment.

Hepatic Impairment: Use of NUPLAZID is not recommended in patients withhepatic impairment. NUPLAZID has not been evaluated in this patientpopulation.

Pediatric Use: Safety and efficacy have not been established inpediatric patients.

Dosage and Administration: Recommended dose: 34 mg per day, takenorally as two 17 mg tablets once daily, without titration.

About ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines to address unmet medical needsin central nervous system disorders. ACADIA maintains a website at www.acadia-pharm.comto which we regularly post copies of our press releases as well asadditional information and through which interested parties cansubscribe to receive e-mail alerts.

Forward-Looking Statements

Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but arenot limited to statements related to the benefits to be derived fromACADIA’s product candidates and from NUPLAZID (pimavanserin); whetherNUPLAZID fills an important therapeutic gap as the first FDA-approvedtreatment for patients afflicted with hallucinations and delusionsassociated with Parkinson’s disease psychosis; whether NUPLAZIDestablishes a new class of drug; whether ACADIA will be able to ensurepatients have access to NUPLAZID; and the assistance that will beavailable to patients, their caregivers and physicians from ACADIA,including through NUPLAZIDconnect. These statements are only predictionsbased on current information and expectations and involve a number ofrisks and uncertainties. Actual events or results may differ materiallyfrom those projected in any of such statements due to various factors,including the risks and uncertainties inherent in drug discovery,development, and commercialization, whether NUPLAZID receives adequatereimbursement from third-party payers, ACADIA’s ability to establish anadequate specialty pharmacy network to distribute NUPLAZID, the degreeto which NUPLAZID receives acceptance from patients and physicians forits approved indication, and the fact that past results of clinicaltrials may not be indicative of future trial results. For a discussionof these and other factors, please refer to ACADIA’s annual report onForm 10-K for the year ended December 31, 2015 as well as ACADIA’ssubsequent filings with the Securities and Exchange Commission. You arecautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. This caution is madeunder the safe harbor provisions of the Private Securities LitigationReform Act of 1995. All forward-looking statements are qualified intheir entirety by this cautionary statement and ACADIA undertakes noobligation to revise or update this press release to reflect events orcircumstances after the date hereof, except as required by law.

Source: ACADIA Pharmaceuticals Inc.

Investor Contact:
ACADIA Pharmaceuticals Inc.
LisaBarthelemy
(858) 558-2871
ir@acadia-pharm.com
or
MediaContact:
Taft and Partners
Ted Deutsch
(609)578-8765
ted@taftandpartners.com

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